FDA-Device2026-04-01Class IIPROCESSING DEFECT
Olympus OER-Pro endoscope reprocessor incompatible with MAJ-1443 and MAJ-1444 adapters
What this means
Olympus has identified that two adapter models (MAJ-1443 and MAJ-1444) are no longer compatible with OER-Pro and OER-Elite automated endoscope reprocessors. This means these adapters cannot be safely used with these reprocessing machines. No injuries have been reported.
- If you use an OER-Pro or OER-Elite reprocessor, verify whether you have MAJ-1443 or MAJ-1444 adapters.
- Do not use MAJ-1443 or MAJ-1444 adapters with your OER-Pro or OER-Elite reprocessor.
- Contact Olympus or your equipment representative for compatible replacement adapters or instructions.
The agency's original wording
Hazard
The MAJ-1443 and MAJ-1444 are no longer reprocessing compatible with the OER-Pro and OER-Elite automated endoscope reprocessors.
Intended for
All ages
Illnesses reported
None reported
Sold states
US Nationwide distribution.
Affected count
3,354 units
Manufactured in
3500 Corporate Pkwy, Center Valley, PA, United States
Products
Olympus Endoscope Reprocessor OER-Pro. Model Number: N3058140.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1613-2026More Olympus recalls
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